Panels › General Hospital › Product code FMI · Class 2
Needle, Hypodermic, Single Lumen
Regulation 880.5570
13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
Top companies in FMI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 1997 | K970398 | SHARPS CONTAINER Custom Medical Plastics, Inc. | FMI |
| Jul 3, 1997 | K970383 | SHARPS CONTAINER Custom Medical Plastics, Inc. | FMI |
| Jun 6, 1997 | K964042 | EXTRESAFE PHLEBOTOMY Specialized Health Products, Inc. | FMI |
| Jun 6, 1997 | K963748 | BIO-PLEXUS DROP-IT NEEDLE HOLDER Bio-Plexus, Inc. | FMI |
| Jun 2, 1997 | K963571 | VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR Vygon Corp. | FMI |
| Apr 25, 1997 | K970380 | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM Pyng Medical Corp., CA | FMI |
| Apr 10, 1997 | K970370 | TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE Tsk Laboratory, Japan, JP | FMI |
| Apr 2, 1997 | K964654 | BECTON DICKINSON BLUNT PLASTIC CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Mar 28, 1997 | K970737 | B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Feb 26, 1997 | K963351 | LIFESHIELD BLUNT CANNULA Abbott Laboratories | FMI |
| Feb 14, 1997 | K965248 | BEMIS TWO GALLON SHARPS CONTAINER Bemis Mfg. Co. | FMI |
| Feb 10, 1997 | K963830 | SHARPS CONTAINER MODEL# SC001 Image Medical, Inc. | FMI |
| Jan 10, 1997 | K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE Manan Medical Products, Inc. | FMI |
| Jan 6, 1997 | K963595 | SERAGARD VASCULAR ACCESS DEVICE Cutting Edge Technologies, Inc. | FMI |
| Dec 23, 1996 | K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA Sherwood Medical Co. | FMI |
| Oct 24, 1996 | K950686 | I.V. START KIT James J. Schramm | FMI |
| Oct 11, 1996 | K962149 | SAFETY CRADLE Specialized Health Products, Inc. | FMI |
| Aug 28, 1996 | K960933 | BIO-PLEXUS NEEDLE DISPOSAL CONTAINER Bio-Plexus, Inc. | FMI |
| Aug 7, 1996 | K961877 | PISTON SYRINGE Univec, Inc. | FMI |
| Jul 8, 1996 | K955772 | CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES Ttk Biomed, Ltd. | FMI |
| Jul 2, 1996 | K961088 | NON-CORING NEEDLE Arrow Intl., Inc. | FMI |
| Jun 27, 1996 | K961878 | SHARPS-TAINER Winfield Industries | FMI |
| Jun 27, 1996 | K961251 | PUNCTUR-GUARD WINGED SET Bio-Plexus, Inc. | FMI |
| Jun 25, 1996 | K962040 | RNS ARTHROGRAM TRAY Contour Fabricators of Florida, Inc. | FMI |
| Jun 25, 1996 | K962035 | GE STERILE ARTHROGRAM TRAY GE Medical Systems | FMI |
| May 30, 1996 | K961328 | BEC SHROUDED PLASTIC CANNULA Biological & Environmental Control Laboratories | FMI |
| May 28, 1996 | K932889 | PERRY SPECIALTIES DESIGNS NEEDLE GUARD Perry Specialties Design, Inc. | FMI |
| May 17, 1996 | K960641 | RECAP-1 Medscience, Inc. | FMI |
| May 6, 1996 | K960963 | CORD WRAP WITH NEEDLE RESHEATHER Osborn Medical Corp. | FMI |
| Apr 15, 1996 | K960698 | NON-CORING NEEDLE Med Institute, Inc. | FMI |
| Mar 14, 1996 | K955748 | DOYLE EXTRACTOR Safetech Intl., Inc. | FMI |
| Feb 29, 1996 | K942073 | SHARPSPRO-TECTOR Superior Diapering Products , Ltd. | FMI |
| Feb 13, 1996 | K952044 | INSULCAP Karen Holtz | FMI |
| Feb 12, 1996 | K955235 | B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Jan 30, 1996 | K952837 | DARWIN HYPODERMIC SAFETY SYSTEM (DHSS) Emk Enterprises, LLC | FMI |
| Jan 18, 1996 | K954500 | HOSPITEC MEDI-BUTLER Hospitec, Inc. | FMI |
| Nov 20, 1995 | K940645 | KEY-LOK(TM) SYSTEM St. Paul Medical | FMI |
| Nov 3, 1995 | K935916 | LIP GRIP CAP HOLDER Daryl C. Fallas | FMI |
| Oct 16, 1995 | K954041 | G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) Glaxo, Inc. | FMI |
| Oct 7, 1995 | K951254 | SAFETYGLIDE NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Oct 3, 1995 | K952834 | SHROUDED PLASTIC CANNULA Medical Associates Network, Inc. | FMI |
| Aug 29, 1995 | K952274 | CHEMOGUARD, P2 HIRISK Biosafety Systems, Inc. | FMI |
| Aug 29, 1995 | K944931 | BECTON DICKINSON BLUNT STEEL CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Aug 18, 1995 | K950012 | DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES International Regulatory Consultants | FMI |
| Jul 28, 1995 | K952518 | SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE Medi-Dose, Inc. | FMI |
| Jul 14, 1995 | K934435 | CAP-STIK Mcshane Medical, Inc. | FMI |
| Jul 12, 1995 | K943057 | CAP SAFE SYSTEM Medical Safety Solutions | FMI |
| Jul 10, 1995 | K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE Devon Industries, Inc. | FMI |
| Jul 10, 1995 | K943765 | SHARPS AWAY Biomedical Waste Systems, Inc. | FMI |
| Jul 10, 1995 | K942930 | CAPCARD Capcard, Inc. | FMI |
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